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The Luminex® FLEXMAP 3D® system with xPONENT® software is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.

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I am sorry, but the provided text is a formal letter from the FDA regarding a 510(k) premarket notification for the Luminex FLEXMAP 3D device. It confirms the substantial equivalence of the device and outlines general regulatory obligations.

The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.

Not Found

The provided text is a 510(k) summary for the Luminex FLEXMAP 3D® Instrument System, not a study report or clinical trial. Therefore, it does not contain the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The document is a letter from the FDA granting substantial equivalence to the device based on its intended use as a clinical multiplex test system for in vitro diagnostic assays. It discusses regulatory compliance and general controls, but not the specific technical performance or validation studies of the device itself.

Therefore, I cannot fulfill your request for the tables and information as it is not present in the provided document.

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The Luminex LX 100/200 Instrument is a clinical multiplex test system intended to measure and sort multiple signals generated in an In Vitro Diagnostic assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.

The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Luminex LX 100/200 Instrument, stating that the device is substantially equivalent to legally marketed predicate devices.

The document includes:

• The device name and 510(k) number.
• The intended use of the device.
• Regulatory information such as regulation number, regulatory class, and product code.

However, it does not contain the following information that you requested:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device